1. Field of the Invention
The present invention relates to a portable and programmable biofeedback system which senses a physiological variable (biosignal), such as heart rate, and both displays the physiological variable in a visual display in real time and activates and deactivates a user prerecorded voice-message upon reaching a user-programmed threshold value for the physiological variable measured.
2. Description of the Prior Art
Biofeedback systems are known in the prior art to be therapeutically useful to monitor and regulate physiological functions and psychological or emotional behavior. Typically, and as is well known in the prior art, various sensory devices are available to translate physiological variables into a visual or an auditory display, thereby allowing a user to monitor the change in values of the physiological variable. Such physiological variables have been measured by various means and include cardiac neuroelectric potentials (electrocardiogram or EKG), muscular neuroelectric potentials (electromyogram or EMG), heart rate (pulse), galvanic skin response (GSR), photoplethysmography (blood vessel enlargement measurement), blood gas values (carbon dioxide and oxygen levels), respiration rate and body temperature. In a biofeedback system, regardless of the variable measured and inputted into the system, the user attempts to adjust those physiological variables in a way which alters the output displayed, thereby learning to control the variable.
Presently, however, a user's control over his or her response to the information displayed and effectiveness in learning therefrom is limited by the type of output or display provided with the biofeedback apparatus. For example, a user may be in need of immediate instruction for modification of a behavioral disorder as a result of an onset, often in public. In other situations, a user may desire or be able to best respond to his or her own created messages, avoiding "burnout" to pre-recorded behavior modification messages. However, the prior art regarding biofeedback devices fails to address the need for a portable, concealable biofeedback apparatus allowing the user to alter the output voice messages to which the user responds and to receive these messages in real-time at the time of a sudden onset.
As found in the prior art, one group of portable units which sense biosignals are dependent upon base units to communicate with a portable user-worn sensing device. The base units then either activate information displays in the base unit or activate intermediate communication means to further translate a signal to a remote site. For example, U.S. Pat. No. 5,375,607 issued Dec. 27, 1994 to Sassagawa discloses a telemeter apparatus for counting a heart rate without being affected by a radio interference between adjacent exercise test systems. The telemeter apparatus has a (1) wireless transmitter unit for transmitting a heart beat signal detected from a subject, (2) receiving coils on each side of a treadmill or similar exercise test system, (3) at least two comparators for accepting and comparing a signal with a predetermined threshold level, (4) an AND circuit to which output signals from the comparators are input, and (5) a heart rate display unit. The comparators, AND circuit and heart rate display all reside in the treadmill.
U.S. Pat. No. 5,228,449 issued Jul. 20, 1993 to Christ et al. describes a wrist worn monitor system and method for detecting out-of-hospital cardiac emergencies and summoning emergency assistance by using a photoplethysmograph to monitor pulse through a wrist-worn unit. The wrist-worn unit communicates by radio frequency with a base unit, which in turn may activate local alarms, an auto-dialer to telephone for help, or other devices to alert rescue authorities. This system is useful in alerting another person that a cardiac event has occurred, but fails to provide voice biofeedback useful to help initially prevent a problem. Both the '607 and '449 patents describe devices that fail to address the purpose of providing a portable and concealable unit for delivering voice messages controlled exclusively by the user.
Another group of both portable and concealable units only provide a very limited audible or visual display of the biosignal sensed, without providing a user input means for changing the output message. For example, the CIC HEARTWATCH.TM. Instruction Manual and Exercise Guide, copyright 1991, describes a commercially available wrist-worn heart rate monitor with means for setting an alarm for an upper and lower exercise heart rate value and LCD display for displaying the heart rate in real time. Electrodes and a transmitter are housed in a chest belt to sense heart signals. Next, U.S. Pat. No. 4,938,228 issued Jul. 3, 1990 to Righter et al. describes a wrist worn heart rate monitor which is intended to display a user's heart rate with a medical grade accuracy during vigorous physical exercise in an LCD display. German Publication No. 29 22 542 published Apr. 12, 1980, describes a user-worn first-alert system which is able to monitor various physiological signals such as heart rate, respiration rate, blood pressure, body temperature and activate an alarm. It is intended for use in a hospital setting or elderly for individuals living alone. None of the inventions so described are linked with a recording/playback device to activate a voice biofeedback message.
A final group of devices is capable of monitoring and recording a biosignal, but none of these devices correlate the activation and deactivation of a message playback and recording device with a predetermined biosignal threshold value input. U.S. Pat. No. 5,245,666 issued Sep. 14, 1993 to Mikell describes a subliminal messaging system including a wide range linear subliminal modulator, a digital audio recording or playback device, a microphone to pick up sound at the ear, and an earpiece to deliver the subliminal message. The basic system allows the user to push a button to record an affirmative message on an internal digital-analog storage chip. When the record button is released, the message is presented, repeatedly, at the earpiece at a user-adjustable amplitude. The '666 patent describes a portable device for self-recording messages with no switching device for intermittent activation of a biofeedback message based on a biofeedback signal. It is important to note in contrast that the concept of activating a prerecorded message for use at the moment that a physiological threshold value is reached is critical to the usefulness of the present invention.
U.S. Pat. No. 5,299,119 issued to Kraf et al. describes a programmable cardio-respiratory monitoring system for performing medical diagnostic autonomic nervous system tests by monitoring and analyzing the peaks and intervals of EKG signals in relation to breathing and/or posture regimens. Although a means by which automated audio-visual instructions can prompt a patient to perform a particular regimen is noted, the instructions are not recordable by the user and no means for easily changing the message or for simple, portable use is described.
The prior art fails to disclose a portable, concealable recording/playback device combined with a biosignal monitoring device so that when the user's measured biosignal value reaches a predetermined value, a user-recorded message is activated. The user is thus able to immediately attempt to regulate the biosignal and affect it in such a way that the output message is deactivated after dropping below a user pre-programmed threshold value. None of the above referenced inventions and patents, taken either singly or in combination, is seen to describe the instant invention as claimed.